VETERINARY MEDICINAL PRODUCTS (VMPs)
LICENSING
Does the law require the authorization/licensing of establishments that manufacture, store, process, distribute or sell VMPs?
2 answers
Regulation 130. (1) (extract) No food, drug, cosmetic or device shall be manufactured in any premises unless there is in force a licence to indicate that the premises ([…]) comply with regulations 115 or 117
Section 24. The principal functions of the Authority under this Act shall be to -(p) regulate and control the manufacture, import, export, use, quality, suitability, packaging, labelling, transport, storage, sale and advertising of any veterinary biological and veterinary medicine.
Section 45. (1) The Minister may, on the advice of the Authority, make subsidiary legislation for the purpose of carrying out the provisions of this Act. (2) Without prejudice to the generality of subsection (I), the Minister may make regulations providing for any of the following - (d) the registration, importation, manufacture, distribution and sale of any veterinary biological, veterinary medicine or animal feed;
Which kind of sanctions are imposed in case of offences (criminal, administrative) related to authorization/licensing to manufacture, store, process, distribute or sell VMPs?
1 answer
Regulation 135. (1) A person who contravenes or fails to comply with any of these regulations shall be guilty of an offence (2) for the avoidance of doubt it is hereby declared that the section 33 of the Act shall apply to any offence referred to paragaph 1
